VALIANT® Captivia VAMF3636C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169347052), received between May 2, 2017 and Mar 20, 2026 — classified as 2 deaths, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Fracture

  A VALIANT CAPTIVIA STENT GRAFT VAMF3636C100TU VALCAP FREFL WAS INTENDED TO BE IMPLANTED DURING A TEVAR PROCEDURE TO TREAT A 39MM AORTIC DISSECTION. IT WAS REPORTED THAT DURING PREPARATION THE DEVICE WAS OPENED AND PRESENTED ONTO THE STERILE FIELD, WHERE THE DEVICE APPEARED DAMAGED PRIOR TO IMPLANTATION. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD AND SECURED, AND A REPLACEMENT VALIANT DEVICE WAS PROMPTLY PROVIDED. THE DAMAGED DEVICE WAS NOT IMPLANTED, AND THE PATIENT WAS NOT EXPOSED TO IT. THE PROCEDURE CONTINUED WITHOUT DELAY USING THE REPLACEMENT PRODUCT, AND THE PATIENT UNDERWENT SUCCESSFUL TEVAR FOR AORTIC DISSECTION. NO PATIENT COMPLICATIONS WERE REPORTED. THE EVENT WAS RESOLVED AS THE DAMAGED DEVICE WAS IDENTIFIED PRIOR TO IMPLANTATION AND REPLACED, WITH THE PROCEDURE COMPLETED AS PLANNED. THERE WAS NO PATIENT INVOLVED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. IT WAS NOTED THAT A SMALL DENT WAS OBSERVED TO THE DEVICE BOX BUT NO INTERNAL DAMAGE SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646869 ↗
• DeathApr 12, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (VNMC3737C90TU & VNMC3737C182TU) WERE IMPLANTED, DURING THE REINTERVENTION OF A PRIOR THORACIC AORTIC REPAIR. THE PATIENT HAD 2 EXISTING VALIANT CAPTIVIA STENT GRAFTS IMPLANTED 5 YEARS PREVIOULSY. IT WAS REPORTED, CORE LAB REVIEW OF CT IMAGING TAKEN APPROXIMATELY 2 YEARS POST. THE NAVION IMPLANT, IDENTIFIED A NEW TYPE II ENDOLEAK. THE MAX AORTIC DIAMETER WAS NOTED, AS 71.MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NOTED, AS NON EVALUABLE FOR STENT FRACTURES. IT WAS NOTED, ON IMAGE REVIEW UNABLE TO FULLY IDENTIFY NAVION DEVICES, BUT LARGEST STRUT MEASURED AND SRE FOR BOTH 37X37 DEVICES.  IT WAS REPORTED, THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE CAUSE OF THE TYPE II ENDOLEAK AND DEATH IS UNDETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 19094726 ↗
• MalfunctionJan 18, 2024Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE ON AN UNKNOWN DATE. A INVESTIGATIONAL DEVICE WAS ALSO IMPLANTED TO TREAT A TAAA. IT WAS REPORTED THAT IN (B)(6) 2023 AN UNKNOWN ENDOLEAK WAS DISCOVERED ON ACT. THE CAUSE OF THE ENDOLEAK WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535391 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE .  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT WHEN USING THE STENT GRAFT, A THORACIC BRANCH VESSEL WAS COVERED.  NO CAUSE OF THE EVENT WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 15630372 ↗
• MalfunctionJan 28, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 40MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PROXIMAL STENT WOULD NOT DEPLOY DURING NORMAL DEPLOYMENT. IT WAS REPORTED THE PHYSICIAN WAS ABLE TO DISMANTLE THE BACK HANDLE AND DEPLOY THE PROXIMAL STENT MANUALLY AND THE EVENT WAS REPORTED TO BE RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8280991 ↗
• DeathMay 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMMERCIALLY AVAILABLE ENDURANT II LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AS PART OF THE IMPLANT OF A NON-COMMERCIALLY AVAILABLE TVAAA DEVICE. IT WAS NOTED THAT THE DIAMETER OF THE AORTA AT THE DIAPHRAGM MEASURED 36 MM AT THE TIME OF INTERVENTION. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED FOR AN EXTENDED PERIOD OF TIME AS IT TOOK LONGER THAN EXPECTED FOR HIM TO WEAN OFF THE VENT. WHILE INTUBATED, AND AFTER EXTUBATION, THE SUBJECT HAD A STRONG COUGH. POST OPERATIVELY, THE PATIENT¿S BLOOD PRESSURE CONTINUED TO INCREASE WITH THE HIGHEST BLOOD PRESSURES MEASURED BEING 232/65 MMHG ON POST OP DAY 2 AND 212/99 MMHG ON POST OP DAY 3. THEY WERE TREATED WITH IV ANTIHYPERTENSIVE MEDICATIONS AS WELL AS HIS HOME REGIMEN OF ANTIHYPERTENSIVE MEDICATIONS TO DECREASE HIS BLOOD PRESSURE. DURING THE TIME OF INCREASED HYPERTENSION, THIS PATIENT HAD SEVERAL SIGNIFICANT COUGHING EVENTS. ON POST OP DAY 6, A CTA OF THE CHEST, ABDOMEN, AND PELVIS WERE COMPLETED AND A RETROGRADE TYPE B AORTIC DISSECTION WAS DISCOVERED IN THE DESCENDING THORACIC AORTA EXTENDING PROXIMALLY FROM THE VTAAA THORACIC BIFURCATION STENT GRAFT. THE PATIENT¿S BLOOD PRESSU

  Patient problems: Death

  MAUDE report 6541473 ↗
• InjuryMay 2, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BELLY AND BACK PAIN. A CT SHOWED THE PATIENT HAD A 3 VESSEL SNORKEL PROCEDURE; AND THAT THE NECK HAD CONTINUED TO DILATE CAUSING A TYPE IA ENDOLEAK TO DEVELOP BETWEEN THE SNORKELS. IT WAS NOTED THAT THE ANEURYSM MEASURED 8 CM IN DIAMETER TWO YEARS AGO BUT WAS 9.5 CM IN DIAMETER AT THE MOST RECENT SCAN. THE PATIENT WAS TAKEN TO THE OR AND ANOTHER MANUFACTURER¿S STENTS WERE PLACED IN THE RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY. A 36X36X100 VALIANT DEVICE WAS ALSO PLACE. AN ANGIOGRAM WAS PERFORMED AND THE ENDOLEAK REMAINED. SIX HELI-FX ENDOANCHORS WERE THEN PLACED, BUT THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN WAS ABLE TO PLACE A WIRE BETWEEN THE SNORKELS AND INJECT THROMBIN INTO THE AREA OF THE ENDOLEAK. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO PATIENT ANATOMY; SPECIFICALLY, DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6538903 ↗